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Re: branster post# 50080

Thursday, 12/05/2019 10:13:51 AM

Thursday, December 05, 2019 10:13:51 AM

Post# of 232118
I have been working 40 years in industry, but when I come to turnaround jobs, I always following the 80/20% rule. 80% done, ok, then what is next bigger issues. In clear text: If 500 mg is already excellent and is much better than anything on the market, why to lose so much time for fine- optimization? Why to apply in such unnecessary way and giving 2 options to decide? I also always following the rule: Who asks much, who will get many answers!

The delay isn't the problem of FDA, NP should have never asked for 725 unless he wouldn't have been sure he would not get the approval for 500 mg, but I understood that everyone was very happy with results of 500 mg.

I am either not sure about the game of BP and FDA, but this was NP's not so smart approach. Many questions...many answers. He is old enough to know this rule.
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